NCT05250505

Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: CereVasc Inc · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The eShunt System includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure. The eShunt Implant is designed to mimic the function of the arachnoid granulations by draining excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.

Detailed description

This is a prospective, non-randomized, open-label, single-center, pilot study in subjects with normal pressure hydrocephalus for whom a traditional CSF shunt implant is indicated. Up to 30 subjects will receive the eShunt Implant at one investigational site. Subjects will return for five follow-up visits in the first year and then continue to attend visits every six months for five years post-implantation. The study objectives are to demonstrate safety of the eShunt Procedure, as well as demonstrate safety and efficacy of the eShunt Implant in a small sample of patients. Subjects will be followed long-term; primary analysis results will be used to support additional studies.

Conditions

• Hydrocephalus, Normal Pressure
• Hydrocephalus

Interventions

Type	Name	Description
DEVICE	eShunt Implant	The eShunt System consists of endovascular delivery componentry and a permanent implant intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system in adults.

Timeline

• Start date: 2022-03-10
• Primary completion: 2025-04-23
• Completion: 2030-04-01
• First posted: 2022-02-22
• Last updated: 2026-03-18

Locations

1 site across 1 country: Argentina

Regulatory

• FDA-regulated device study